Articles

Archive for April, 2012

Supplements and cancer prevention

The bloggers here have been very critical of a law passed nearly 20 years ago, commonly referred to as the DSHEA of 1994. The abbreviation DSHEA stands for about as Orwellian a name for a law as I can imagine: the Dietary Supplement Health and Education Act. Of course, as we’ve pointed out time and time again, the DSHEA is not about health, and it’s certainly not about education. Indeed, perhaps my favorite description of this law comes from our very own Peter Lipson, who refers to it as a “travesty of a mockery of a sham.” Rather, it’s about allowing supplement manufacturers and promoters of so-called “complementary and alternative medicine” (CAM, with or without a preceding “s,” depending on your taste) who do not want pesky things like government laws and regulations to interfere with their selling of pseudoscience to market various compounds as “dietary supplements” with near-impunity. As Harriet Hall put it so accurately, the DSHEA is “a stealth weapon that allows the sale of unproven medicines just as long as you pretend they are not medicines.”

The DSHEA accomplishes this by making a seemingly reasonable distinction between food and medicine and twisting it in such a way that allows manufacturers to label all sorts of botanicals and various other compounds, many of which have substances in them with pharmacological activity, and sell them as “supplements” without prior approval by the FDA before marketing. As long as the manufacturer is careful enough not to make health claims that are too specific, namely that the supplement can diagnose or treat any specific disease, and sticks to “structure-function” statements (“it boosts the immune system!”), almost anything goes, particularly if a Quack Miranda Warning is included.

Not surprisingly, given what a big business supplements have become in this country largely due to the DSHEA, manufacturers and CAM advocates fight tooth and nail against any attempt to update the DSHEA to correct some of its more unfortunate consequences. Led by Utah Senator Orrin Hatch and Iowa Senator Tom Harkin, who together make up a bipartisan tag-team in defense of the supplement industry and do their best to block any effort to increase its regulation by the FDA. We saw that most recently when Arizona Senator John McCain, of all people, introduced a bill in 2010 to try to tighten up the DSHEA and was thoroughly slapped down by Orrin Hatch. More recently, not satisfied with how good things are for the supplement industry, another Utah Representative Jason Chaffetz reached across the aisle to Jared Polis, teaming up to introduce the Free Speech About Science Act, which basically seeks to allow the supplement industry to make more liberal claims about its products. All it will need is a “peer-reviewed” paper to support it (Mark and David Geier would do!), and you can claim almost anything. Anything to grow the supplement industry, which is currently around $30 billion a year.

That’s why it’s critical, from time to time, to look at actual evidence, and just last week Maria Elena Martinez, PhD, of the University of California San Diego, and co-authors did in a commentary published online in the Journal of the National Cancer Institute entitled Dietary Supplements and Cancer Prevention: Balancing Potential Benefits Against Proven Harms.
(more…)

Posted in: Cancer, Herbs & Supplements, Politics and Regulation

Leave a Comment (67) →

Consumer Reports and Alternative Therapies

Consumer Reports (CR) and its Health Newsletter provide sound advice about nutrition and medicine, with one exception: their recommendations concerning alternative therapies, especially dietary supplements. With regard to dietary supplements, part of the problem is the failure of CR to make a distinction between authentic dietary supplements, such as multivitamins and minerals, and non-vitamin, non-mineral medicinal products. For example, the September 2010 issue of CR contains a table listing “Eleven supplements to consider”. The list includes calcium and vitamin D supplements, and St. John’s wort and Pygeum herbals.

The nomenclatural confusion was created by the Dietary Supplement Health and Education Act of 1994 (DSHEA), which was termed “The Snake Oil Protection Act” by the New York Times. DSHEA, which was passed after a massive lobbying campaign by industry, arbitrarily designated herbals and other traditional medicinal products as dietary supplements. Herbals are used worldwide as medicines and in Europe some are available by prescription only.

The purpose of the Act was to prevent the Food and Drug Administration (FDA) from effectively regulating those products, and it succeeded brilliantly. Sales of dietary supplements rose from $4 billion annually in 1994 to $28 billion in 2007, and reports of severe adverse events caused by those products rose in parallel (1). Another consequence of DSHEA is that designating herbals as dietary supplements misleads consumers about their medicinal nature and conceals their potential for causing severe adverse effects.

The selling points for herbals are that as “natural” products they are safer and gentler than the powerful “foreign” chemicals in purified medications, and they possess unique qualities not found in conventional medications. Dr. Varro Tyler, an expert in the medicinal use of plants, termed those unfounded claims “paraherbalism”, and described herbals as “crude drugs of vegetable origin” (2). In reality, the active ingredients of plants are chemicals that are similar or identical to conventional medications, and many of the latter were first identified in plant extracts. It is no more “natural” to swallow dozens of chemicals in a plant extract than to ingest a single purified chemical – a drug is a drug. Before discussing CR’s advice about supplements, it is necessary to consider briefly basic differences between herbals and conventional medications.

(more…)

Posted in: Herbs & Supplements, Legal, Science and the Media

Leave a Comment (60) →

Gold mine or dumpster dive? A closer look at adverse event reports

All informed health decisions are based on an evaluation of expected risks and known benefits. Nothing is without risk. Drugs can provide an enormous benefit, but they all have the potential to harm. Whether it’s to guide therapy choices or to ensure patients are aware of the risks of their prescription drugs, I spend a lot of time discussing the potential negative consequences of treatments. It’s part of my dialogue with consumers: You cannot have an effect without the possibility of an adverse effect. And even when used in a science-based way, there is always the possibility of a drug causing either predictable or idiosyncratic harm.

An “adverse event” is an undesirable outcome related to the provision of healthcare. It may be a natural consequence of the underlying illness, or it could be related to a treatment provided. The use of the term “event” is deliberate, as it does not imply a cause: it is simply associated with an intervention. The term “adverse reaction,” or more specifically “adverse drug reaction,” is used where a causal relationship is strongly suspected. Not all adverse events can be be causally linked to health interventions. Consequently, many adverse events associated with drug treatments can only be considered “suspected” adverse drug reactions until more information emerges to suggest the relationship is likely to be true.

Correlation fallacies can be hard to identify, even for health professionals. You take a drug (or, say, are given a vaccine). Soon after, some event occurs. Was the event caused by the treatment? It’s one of the most common questions I receive: ”Does drug ‘X’ cause reaction ‘Y’?” We know correlation doesn’t equal causation. But we can do better than dismissing the relationship as anecdotal, as it could be real. Consider an adverse event that is a believed to be related to drug therapy: (more…)

Posted in: Epidemiology, Pharmaceuticals

Leave a Comment (24) →

Hypnotherapy For Pain and Other Conditions

Hypnotherapy is the use of hypnosis as a medical intervention, usually for the treatment of pain and other subjective symptoms. It remains controversial, primarily because the evidence for its efficacy is not yet compelling, but also because it is poorly understood. This situation is not helped by the fact that it is often characterized as an “alternative” therapy, a label that can “ghettoize” an otherwise legitimate treatment modality.

What Is Hypnosis?

Any meaningful discussion of hypnosis, or any other phenomenon, needs to start with a specific, and hopefully operational, definition.  If we cannot define hypnosis then it becomes impossible to meaningfully discuss it. The problem of definition plagues the science dealing with many so-called alternative therapies, such as acupuncture.  Good science requires controlling for specific variables, so that we can determine which variables are having what effects. If we don’t know which variables are part of the operational definition of a specific therapy, then we cannot conduct proper studies or interpret their results.

For example, with acupuncture, in my opinion the only meaningful definition of this procedure is the placing of thin needles into specific acupuncture points in order to elicit a specific response. Research has shown, however, that acupuncture points do not exist, that placing needles at specific points is not associated with a specific outcome, and even that sticking needles through the skin (as opposed to just poking the skin superficially) does not correlate with outcome. When these variables are isolated they do not appear to contribute anything to efficacy, therefore one might conclude that acupuncture does not work. Research into acupuncture, however, often does not adequately isolate these variables from the therapeutic ritual that surrounds acupuncture, or even mixes in other modalities, such as electrical stimulation.

(more…)

Posted in: Neuroscience/Mental Health

Leave a Comment (21) →

Chiropractors as Family Doctors? No Way!

A recent three-part article published in ACA News advocates turning chiropractors into “conservative primary care providers” who would be the initial point of contact for patients, would serve as gatekeepers for referrals to medical doctors and specialists, and would co-manage patients with those specialists on a continuing basis: essentially, family doctors.  I think that’s a terrible idea. It might benefit chiropractors by increasing their market share, but it wouldn’t benefit patients. There is no evidence to indicate that chiropractors are capable of filling that role effectively or safely.

NUHS. The article was co-authored by several chiropractors on the faculty of the National University of Health Sciences, a school noted for integrating quackery with medicine. The “sciences” this school teaches are listed at the top of its website: chiropractic medicine, naturopathic medicine, oriental medicine, acupuncture, biomedical science, and massage therapy. The only one of those that even sounds like science, “biomedical science,” offers a bachelor of science degree with an integrative medicine focus and with no required core courses whatsoever!

Their doctor of chiropractic degree program says:

National University prepares students to become first-contact, primary care physicians fully qualified to diagnose, treat and manage a wide range of conditions.

(more…)

Posted in: Chiropractic, Politics and Regulation

Leave a Comment (349) →

The problem with preclinical research? Or: A former pharma exec discovers the nature of science

If there’s one thing about quacks, it’s that they are profoundly hostile to science. Actually, they have a seriously mixed up view of science in that they hate it because it doesn’t support what they believe. Yet at the same time they very much crave the imprimatur that science provides. When science tells them they are wrong, they therefore often try to attack the scientific method itself or claim that they are the true scientists. We see this behavior not just in quackery but any time scientific findings collide with entrenched belief systems, for example, medicine, evolution, anthropogenic global warming, and many others. So it was not surprising that a rant I saw a few weeks ago by a well-known supporter of pseudoscience who blogs under the pseudonym of Vox Day caught my interest. Basically, he saw a news report about an article in Nature condemning the quality of current preclinical research. From it, he draws exactly the wrong conclusions about what this article means for medical science:

Fascinating. That’s an 88.6 percent unreliability rate for landmark, gold-standard science. Imagine how bad it is in the stuff that is only peer-reviewed and isn’t even theoretically replicable, like evolutionary biology. Keep that figure in mind the next time some secularist is claiming that we should structure society around scientific technocracy; they are arguing for the foundation of society upon something that has a reliability rate of 11 percent.

Now, I’ve noted previously that atheists often attempt to compare ideal science with real theology and noted that in a fair comparison, ideal theology trumps ideal science. But as we gather more evidence about the true reliability of science, it is becoming increasingly obvious that real theology also trumps real science. The selling point of science is supposed to be its replicability… so what is the value of science that cannot be repeated?

No, a problem with science as it is carried out by scientists in the real world doesn’t mean that religion is true or that a crank like Vox is somehow the “real” intellectual defender of science. Later, Vox doubles down on his misunderstanding by trying to argue that the problem in this article means that science is not, in fact, “self-correcting.” This is, of course, nonsense in that the very article Vox is touting is an example of science trying to correct itself. Be that at it may, none of this is surprising, given that Vox has demonstrated considerable crank magnetism, being antivaccine, anti-evolution, an anthropogenic global warming denialist, and just in general anti-science, but he’s not alone. Quackery supporters of all stripes are jumping on the bandwagon to imply that this study somehow “proves” that the scientific basis of medicine is invalid. A writer at Mike Adams’ wretched hive of scum and quackery, NaturalNews.com, crows:

Begley says he cannot publish the names of the studies whose findings are false. But since it is now apparent that the vast majority of them are invalid, it only follows that the vast majority of modern approaches to cancer treatment are also invalid.

But does this study show this? I must admit that it was a topic of conversation at the recent AACR meeting, given that the article was published shortly before the meeting. It’s also been a topic of e-mail conversations and debates at my very own institution. But do the findings reported in this article mean that the scientific basis of cancer treatment is so off-base that quackery of the sort championed by Mike Adams is a viable alternative or that science-based medicine is irrevocably broken?

Not so fast there, pardner…
(more…)

Posted in: Basic Science, Cancer, Clinical Trials

Leave a Comment (16) →

Spring Update on Prior Posts

Although I write the definitive entries on topics in this blog, new information trickles in after publication.  The new studies are often not worth an entire entry, recapitulating prior essays, but the new information is still worth a mention.  What follows are updates on topics covered in  prior SBM posts.

Raw Milk

In Oregon we are having a small outbreak of infections from consumption of raw milk.  Not a surprise, since milk is a wonderful culture media and the udder is just down the gravity well from the cows anus.  Raw milk violates the classic dictum “Don’t shit where you eat” although I understand the saying concerned dating in its original conception.

Although the sale of raw milk is illegal in muchof the US,  the law can be bypassed by owning the cow rather than buying the milk,  a reverse of dating advice.  Such is the case in Oregon, where 48 people are time sharing the cows responsible for the current outbreak.  There has been the spread of pathogenic E. coli to at least 5 people, mostly  children, and has lead to the hospitalization of at least 3 children.

Of course, it is hard to get infected. Humans have lived in Filth and Squalor (like Minneapolis and St. Paul or Buda and Pest) for centuries, drinking and eating contaminated food and enough survived perpetuate the species.  Most infections in the past would have been from consuming contaminated food and drink.  I have wondered if the reason fevers are often associated with diarrhea and/or vomiting is that it an evolved response for removing infected material as soon as possible.
(more…)

Posted in: Acupuncture, Herbs & Supplements, Homeopathy, Nutrition

Leave a Comment (39) →

The CAM Docket: Boiron II

Five consumer lawsuits are pending in the U.S. against Boiron, the world’s largest manufacturer of homeopathic products. One lawsuit is also pending in Canada. As reported in a previous post, the U.S. plaintiffs claim they purchased homeopathic products, such as Coldcalm, Oscillo, Arnicare and Chestal Cough Syrup, based on Boiron’s misleading and false statements that they are effective for various ailments. Therefore, these plaintiffs allege, Boiron has defrauded consumers, as well as violated various consumer protection laws. Boiron denies these claims.

The plaintiffs’ allegations in each of the five U.S. lawsuits are based in part on the same fallacies underlying homeopathy discussed many times before here at SBM:

we can summarize . . . by saying it has extreme implausibility and the clinical evidence shows lack of efficacy. It should not work, and it does not work. There is no legitimate controversy about this.

Which raises an interesting question: how does one defend a product that appears to be indefensible? Let’s take a look. (more…)

Posted in: Health Fraud, Homeopathy, Legal, Politics and Regulation

Leave a Comment (26) →

The Skeptical Clinician

All scientists should be skeptics. Serious problems arise when a less-than-skeptical approach is taking to the task of discovery. Typically the result is flawed science, and for those significantly lacking in skepticism this can descend to pseudoscience and crankery. With the applied sciences, such as the clinical sciences of medicine and mental therapy, there are potentially immediate and practical implications as well.

Clinical decision making is not easy, and is subject to a wide range of fallacies and cognitive pitfalls.  Clinicians can make the kinds of mental errors that we all make in our everyday lives, but with serious implications to the health of their patients. It is therefore especially important for clinicians to understand these pitfalls and avoid them – in other words, to be skeptics.

It is best to understand the clinical interaction as an investigation, at least in part. When evaluating a new patient, for example, there is a standard format to the “history of present illness,” past medical history, and the exam. But within this format the clinician is engaged in a scientific investigation, of sorts. Right from the beginning, when their patient tells them what problem they are having, they should be generating hypotheses. Most of the history taking will actually be geared toward testing those diagnostic hypotheses.

(more…)

Posted in: Science and Medicine

Leave a Comment (12) →

The Future of Medicine

Eric Topol, MD, has written a book about the convergence of the digital revolution and medicine. It is full of fascinating information and prognostication, but I wish he had given it a better title.  He called it The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Health Care. Medicine will not and cannot be “destroyed.” It will be improved and transformed, perhaps, but not destroyed. And any new developments will have to be evaluated for safety and effectiveness by the good old time-tested methods of science.

The future world of medicine is really exciting: science fiction is becoming real. As I read Topol’s  book I serendipitously found it paraphrased by a character in another book I was reading, Chop Shop, by Tim Downs.

I see a world where no one ever dies from an adverse drug reaction; where physicians have an entire range of medicines to choose from to treat a deadly disease; where medications target tumors like smart bombs and leave surrounding tissues unharmed; where genetic susceptibility to disease can be determined in childhood, and possibly even prevented.

(If you haven’t yet discovered Downs’ hilarious “Bug Man” detective series about a crazy forensic entomologist, you have a treat in store.)

But back to non-fiction. Our world is changing almost too rapidly to comprehend: the Internet reaches everywhere, and there are far more mobile phones in the world today than toilets.  We have hardly begun to tap the current potential of new technologies, and unimagined further developments await us. Topol is a qualified guide to this new world: he is a respected cardiologist and geneticist who ha s been on the forefront of wireless medicine and who was a major whistleblower in the Vioxx fiasco. He knows whereof he speaks, and he writes lucidly and accessibly.
(more…)

Posted in: Book & movie reviews, Science and Medicine

Leave a Comment (21) →
Page 1 of 3 123